Progressive dementia afflicts millions of people, ultimately entailing precipitous mental decline and years of complete dependence on others. Many people deem the prospect of serious cognitive dysfunction, helplessness, and dependence to be intolerably degrading (as well as overly burdensome on others). To avoid being mired in prolonged dementia, they prefer to hasten death by advance instructions rejecting life-sustaining medical intervention at a point of decline they define as unacceptable.Some health care providers resist implementation of such advance instructions, especially as applied to patients with dementia who are not ostensibly suffering in their demented states and no longer recall their prior instructions and the dignity concerns that underlay them. The clash between advance wishes to hasten death and some health care providers' preference to maintain the well-being of nonsuffering patients will be surfacing, in coming years, in institutional ethics committees, professional disciplinary forums, and the courts. This article defends the legal and moral status of advance instructions seeking to shorten the unwanted limbo of deep dementia.
As the opioid crisis in the United States evolved, so did the relationship between prescribers and pharmaceutical companies that manufacture prescription opioids, with policymakers at both the state and national levels focused on the issue of prescription opioid misuse. This article discusses the role of the prescriber-pharmaceutical company relationship with respect to opioid over- and underprescribing, the evolution of that relationship over time, and its contribution to what is now commonly known as the U.S. opioid crisis or overdose epidemic. The United States saw several "waves" of prescription opioid misuse, and this article characterizes the relationship between prescribers and pharmaceutical companies in similar waves. The article proposes several prescriber- and manufacturer-focused "solutions" that can be implemented to address and lessen the effects of the ongoing crisis. Changes directed at prescribers and manufacturers must be implemented in tandem to ensure such solutions do not, in attempting to fill the existing cracks in the system, create even more.
We examine the evolution of policies permitting exceptions to or waivers of informed consent for research in the United States. This review reveals that (1) exceptions to the duty to secure informed consent were originally quite narrow; (2) there were two alternative approaches to allowing research on human subjects without their prospective consent: (i) exceptions in which individual capacity to consent is to be assessed and consent tailored to each person's abilities and (ii) waivers of the general requirement for a population of potential subjects, where securing prospective consent would "destroy or invalidate" critically important research; (3) waivers only appeared in the final rulemakings for research regulations issued by the National Institute of Education in 1974 and the Department of Health and Human Services in 1981, limiting the opportunity for the public to weigh in on the scope and use of waivers; and (4) rules adopted since 1981 have almost uniformly added extra requirements to justify waivers. Examples drawn from recent research show expansion of the use of waivers far beyond the bounds originally envisioned. Greater transparency about the use of waivers is needed for the public to weigh in on the standards for foregoing informed consent in human research.
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